Progestogen-only pill

Last updated
Progestogen-only pill
Background
TypeHormonal
First use1968 [1] [2]
Failure rates (first year)
Perfect use0.3% [3]
Typical use9% [3]
Usage
Duration effect1 day
ReversibilityYes
User remindersTaken within same 3-hour window each day
Clinic review6 months
Advantages and disadvantages
STI protectionNo
WeightNo proven effect
Period disadvantagesLight spotting may be irregular
Period advantagesOften lighter and less painful
Medical notes
Unaffected by being on most (but not all) antibiotics. May be used, unlike COCPs, in patients with hypertension and history of migraines. Affected by some anti-epileptics.

Progestogen-only pills (POPs), colloquially known as "mini pills", are a type of oral contraceptive that contain synthetic progestogens (progestins) and do not contain estrogens. [4] They are primarily used for the prevention of undesired pregnancy, although additional medical uses also exist. [5]

Contents

Progestogen-only pills differ from combined oral contraceptive pills (COCPs), which instead consist of a combination of synthetic estrogens and progestin hormones. [6]

Terminology

"Progestogen-only pills", "Progestin-only pills", and "Progesterone-only pills" are terms each referring to the same class of synthetic hormone medications. The phrase "Progestogen-only pill" is used by the World Health Organization and much of the international medical community. [7] The phrase "Progestin-only pills" is typically used in the United States and Canada. [8]

Despite sometimes being referred to as "Progesterone-only pills", these medications do not contain progesterone but instead one of several chemically related compounds. [9] For example, the medication Opill contains the synthetic hormone Norgestrel, which has some distinct chemical differences despite producing a similar physiological effect. [10]

Chemical structure of Progesterone, a natural steroid hormone produced in the human body. Progesterone.svg
Chemical structure of Progesterone, a natural steroid hormone produced in the human body.
Chemical structure of Norgestrel, a synthetic steroid hormone used in the brand name medication Opill. Norgestrel Structure.svg
Chemical structure of Norgestrel, a synthetic steroid hormone used in the brand name medication Opill.

Available formulations

Progestogens share the common feature of being able to bind to the body's progesterone receptors and enact a physiological effect similar to naturally occurring progesterone. [11] Still, there are differences between progestogens, and various organizational systems exist to categorize the progestogen hormones used in oral contraception medications.

By Generation - based on when it became available for use, each synthetic hormone can be grouped into 1 of 4 generations of medications. [12] A medication's generation is not necessarily a reflection of safety or efficacy.

By Additional Receptor Activity - each medication may act upon other receptors such as androgen receptors, estrogen receptors, glucocorticoid receptors, and mineralocorticoid receptors. Additional interactions may be positive, increasing activity at a given receptor, or negative, decreasing activity at a given receptor. The overall profile of these additional actions for each medication can be used to describe and contrast progestogens. [13]

Progestogen-only pill formulations: [12] [14] [15] [16] [17]
Generic Formulation (Dose)GenerationBrand name(s)Additional receptor activity
Desogestrel (75 μg)3rdCerazette

Cerelle

Gonadotropin (-)

Estrogen (-)

Androgen (+)

Drospirenone (4 mg)4thSlyndGonadotropin (-)

Estrogen (-)

Androgen (-)

Mineralocorticoid (-)

Norethisterone (350 μg)1stMicronor

Nor-QD

Noriday

Gonadotropin (-)

Estrogen (-/+)

Pro-androgen (+)

Coagulation (+)

Norgestrel (0.075 mg)2ndOpill
Etynodiol diacetate (500 μg)1stFemulen
Levonorgestrel (30 μg)2nd28 mini

Microval

Norgeston

Gonadotropin (-)

Estrogen (-)

Androgen (+)

Lynestrenol (500 μg)1stExluton

Mini-kare

Gonadotropin (-)

Estrogen (-/+)

Androgen (+)

Norethindrone or Norethisterone (300 μg)1stCamila

Mini-Pe

Errin

Heather

Jolivette

Micronor

Nor-QD

Nora-BE

Lyza

Sharobel

Deblitane

Gonadotropin (-)

Estrogen (-/+)

Androgen (+)

Coagulation (+)

Norgestrel (75 μg) or Levonorgestrel (37.5 μg)2ndMinicon

Neogest

Ovrette

Opill

Gonadotropin (-)

Estrogen (-)

Androgen (+)

Chlormadinone acetate (0.5 mg)1stBelara

Lutéran

Prostal

Quingestanol acetate (0.3 mg)-Demovis

Pilomin

In the United States, progestogen-only pills are available in 350-μg Norethisterone, 4-mg Drospirenone and Norgestrel 0.075-mg formulations. [18] Norgestrel is FDA-approved for over-the-counter availability, [19] and Norethindrone and Drospirenone are available by prescription.

Medical uses

Progestogen-only pills are one management option for the suppression of menstruation to avoid pregnancy. [20]

With "perfect use", the efficacy of progestogen-only pills in avoiding unintended pregnancy has been found to be greater than 99%, meaning that less than 1 out of every 100 patients will experience undesired pregnancy within the first year of use. [16] "Perfect use" means that an individual uses their contraceptive pill at the same time every day without missing a scheduled dose. [21]

Assuming "typical use", the theoretical efficacy of progestogen-only pills in avoiding undesired pregnancy falls to around 91-93%, meaning that approximately 7 to 9 out of every 100 patients will experience an unintended pregnancy within the first year of use. [22] [23] "Typical use" means that an individual uses their contraceptive pill at inconsistent times day to day and/or misses scheduled doses. [21] The study reporting the "typical use" failure rate failed to differentiate COCPs and POPs as distinct medications and instead studied them as a combined group, decreasing the validity of this finding. The results were published before the widespread use of progestogen-only pills other than Norethindrone and may not be applicable to formulations that have since been developed. Reported efficacy varies between types of progestogen-only pills. For example, Norgestrel has a reported failure rate of 2%, [24] and Drosperinone has a reported failure rate of 1.8%. [25]

Some progestogen-only formulations, such as those containing Norethindrone, were thought to have a shorter duration of effect than COCPs. [26] As a result, current guidelines recommend no more than 27 hours between doses to ensure effectiveness, creating a 3-hour window of variability. [27] However, a more recent meta-analysis suggested that there is actually a significantly longer half-life for many of the now available progestogen-only pill formulations. For example, Norgestrel and Drosperinone, in particular, appear to have a longer window of efficacy. More variation in dose timing may still effectively prevent pregnancy. [28] Although the 3-hour window is still widely respected, some researchers have expressed their belief that an update to these guidelines may be beneficial. [29]

Mechanism of action

Depending on the specific progestogen and its corresponding dose, the contraceptive effect of progestogen-only pills is enacted through combinations of the following mechanisms: [30]

Breastfeeding

Patients who have recently given birth may benefit from contraception, as experiencing another pregnancy within six months of delivery is associated with poor outcomes for the second pregnancy. [35] Lactational amenorrhea, although a common and effective method of preventing unwanted pregnancy following childbirth, may not be attainable for mothers who elect for or require supplemental or total child feeding with formula. [36] Combined oral contraceptives are not typically recommended until six months following delivery. Progestogen-only pills, however, can be a viable contraceptive option for patients immediately following delivery regardless of breastfeeding habits. [23]

Comparison to combined oral contraceptives

Patient groups who choose COCPs versus 'progestogen-only pills may also differ in important ways, as progesterone-only pills are often preferentially prescribed to subfertile groups such as recently postpartum women or older women. Progestogen-only pills may also be prescribed for individuals wanting an oral form of birth control but do not wish to use estrogen-containing methods due to medical contraindications, intolerable side effects, or personal preference. [8] Examples of contraindications to estrogen-containing methods of contraception include relatively common conditions such as hypertension, migraine headaches with aura, or a history of pulmonary embolism or deep vein thrombosis. [37] On the other hand, progestogen-only pills are safe for use by all these groups. [38] The progestogen-only pill is also recommended for people who have recently given birth and desire a pill for contraception, given the risk of blood clots for both postpartum patients and people using estrogen-containing methods of contraception. [39]

Abnormal uterine bleeding

Given their ability to impact the menstrual cycle and stabilize the endometrial lining of the uterus, progestogen-only pills may also be used to treat various patterns of abnormal uterine bleeding. [40]

Patients with unexplained, abnormal uterine bleeding should be evaluated by a medical professional either through appointment or through a visit to the emergency department. The initial assessment of abnormal uterine bleeding typically focuses on ensuring the patient is medically stable and not in any immediate danger from the underlying cause or associated blood loss. The PALM-COEIN classification system has been developed to understand well-known causes of abnormal uterine bleeding in reproductive-age patients. [41] Understanding the underlying cause of bleeding is an important part of determining the best next step for treatment in each patient's circumstance. Generally, the treatment of abnormal uterine bleeding focuses on controlling the current episode of bleeding and reducing further blood loss in future menstrual cycles or acute episodes.[ citation needed ]

Depending on the presumed underlying cause of bleeding, medical management with progestogen-only pills, combined oral contraceptives, or tranexamic acid may be appropriate. One study found that 76% of patients who took oral medroxyprogesterone acetate (20 mg) for treatment of bleeding unrelated to pregnancy saw resolution of their bleeding. The median time to resolution was 3 days from beginning medical therapy. [42]

The decision to use POPs to treat abnormal uterine bleeding should be made in consultation with a medical professional who can offer guidance on the appropriateness of this treatment option.[ citation needed ]

Adenomyosis

Patients with adenomyosis may be prescribed progestogen-only pills as a part of their treatment. Through their ability to cause amenorrhea, progestogen-only pills can help reduce the symptoms associated with this condition. Levonorgestrel-IUDs may be more effective than progestogen-only pills and reducing associated bleeding (maintaining healthy hemoglobin levels), uterine volume, and pain, although both methods have shown a beneficial impact. That being said, there is currently no definitive treatment guideline, and management can be tailored based on the patient's medical history, preferences, and response to treatment. [43]

Endometriosis

Patients experiencing mild to moderate pelvic pain from endometriosis may be given non-steroidal anti-inflammatory drugs (NSAIDs) as well as hormonal contraceptives (COCPs or POPs) to help manage their symptoms. For a long time, combined oral contraceptives have been used as the first-line hormonal contraceptive (vs. progestogen-only pills) for the treatment of endometriosis. However, progestogen-only pills, including dienogest, medroxyprogesterone acetate, norethisterone, and cyproterone, are also effective in treating symptoms (i.e., pain, excess uterine bleeding), reducing associated lesions, and improving patient quality of life. [44] [45] Recognizing that some patients cannot receive combined oral contraceptives due to a contraindication to the estrogen component, these findings show promise that progestogens can be an alternative therapy capable of producing adequate symptom relief. Progestogen-only pills are typically not given to patients experiencing severe symptoms.[ citation needed ]

Decreased likelihood of malignancy

Daily progesterone use decreases the risk of endometrial cancer, [46] whereas it is unclear whether POPs provide protection against ovarian cancer to the extent that COCPs do.[ citation needed ]

Side effects

Genitourinary

Breast cancer risk

Epidemiological evidence on POPs and breast cancer risk is based on much smaller populations of users and so is less conclusive than that for COCPs.

In the largest (1996) reanalysis of previous studies of hormonal contraceptives and breast cancer risk, less than 1% were POP users. Current or recent POP users had a slightly increased relative risk (RR 1.17) of breast cancer diagnosis that just missed being statistically significant. The relative risk was similar to that found for current or recent COCP users (RR 1.16), and, as with COCPs, the increased relative risk decreased over time after stopping, vanished after 10 years, and was consistent with being due to earlier diagnosis or promoting the growth of a preexisting cancer. [51] [52]

The most recent (1999) IARC evaluation of progestogen-only hormonal contraceptives reviewed the 1996 reanalysis as well as 4 case-control studies of POP users included in the reanalysis. They concluded that: "Overall, there was no evidence of an increased risk of breast cancer". [53]

Recent anxieties about the contribution of progestogens to the increased risk of breast cancer associated with HRT in postmenopausal women such as found in the WHI trials [54] have not spread to progestogen-only contraceptive use in premenopausal women. [30]

Depression

There is a growing body of research investigating the links between hormonal contraception, such as the progestogen-only pill, and potential adverse effects on women's psychological health. [55] [56] [57] The findings from a large Danish study of one million women (followed-up from January 2000 to December 2013) were published in 2016, and reported that the use of hormonal contraception, particularly amongst adolescents, was associated with a statistically significant increased risk of subsequent depression. [56] The authors found that women on the progestogen-only pill in particular, were 34% more likely to subsequently take anti-depressants or be given a diagnosis of depression, in comparison with those not on hormonal contraception. [56] In 2018, a similarly large nationwide cohort study in Sweden amongst women aged 12–30 (n=815,662) found an association, particularly amongst adolescents aged 12–19, between hormonal contraception and subsequent use of psychotropic drugs. [55] Still, the results of these studies are inconclusive because they are observational and cannot establish causality. Additionally, the studies do not account for the possibility of confounding factors, such as preexisting health conditions, which could influence the results. [58]

Weight gain

There is some evidence that progestogen-only contraceptives may lead to slight weight gain (on average less than 2 kg in the first year) compared to women not using any hormonal contraception. [59]

History

The first POP to be introduced contained 0.5 mg chlormadinone acetate and was marketed in Mexico and France in 1968. [1] [2] [17] However, it was withdrawn in 1970 due to safety concerns pertaining to long-term animal toxicity studies. [1] [2] [17] Subsequently, levonorgestrel 30 μg (brand name Microval) was marketed in Germany in 1971. [60] [61] It was followed by a number of other POPs shortly thereafter in the early 1970s, including etynodiol diacetate, lynestrenol, norethisterone, norgestrel, and quingestanol acetate. [60] [62] Desogestrel 75 μg (brand name Cerzette) was marketed in Europe in 2002 and was the most recent POP to be introduced. [63] [62] [64] It differs from earlier POPs in that it is able to inhibit ovulation in 97% of cycles. [62] [64]

In July 2023, the USA Food and Drug Administration (FDA) approved the first over-the-counter (OTC) POP birth control pill to be sold without a prescription in the United States. The pill, marketed under the brand name Opill, is once daily 0.075 mg oral norgestrel. [65]

See also

Related Research Articles

<span class="mw-page-title-main">Emergency contraception</span> Birth control measures taken after sexual intercourse

Emergency contraception (EC) is a birth control measure, used after sexual intercourse to prevent pregnancy.

<span class="mw-page-title-main">Combined oral contraceptive pill</span> Birth control method which is taken orally

The combined oral contraceptive pill (COCP), often referred to as the birth control pill or colloquially as "the pill", is a type of birth control that is designed to be taken orally by women. It is the oral form of combined hormonal contraception. The pill contains two important hormones: a progestin and estrogen. When taken correctly, it alters the menstrual cycle to eliminate ovulation and prevent pregnancy.

<span class="mw-page-title-main">Progestogen (medication)</span> Medication producing effects similar to progesterone

A progestogen, also referred to as a progestagen, gestagen, or gestogen, is a type of medication which produces effects similar to those of the natural female sex hormone progesterone in the body. A progestin is a synthetic progestogen. Progestogens are used most commonly in hormonal birth control and menopausal hormone therapy. They can also be used in the treatment of gynecological conditions, to support fertility and pregnancy, to lower sex hormone levels for various purposes, and for other indications. Progestogens are used alone or in combination with estrogens. They are available in a wide variety of formulations and for use by many different routes of administration. Examples of progestogens include natural or bioidentical progesterone as well as progestins such as medroxyprogesterone acetate and norethisterone.

<span class="mw-page-title-main">Levonorgestrel</span> Hormonal medication used for birth control

Levonorgestrel is a hormonal medication which is used in a number of birth control methods. It is combined with an estrogen to make combination birth control pills. As an emergency birth control, sold under the brand names Plan B One-Step and Julie, among others, it is useful within 72 hours of unprotected sex. The more time that has passed since sex, the less effective the medication becomes, and it does not work after pregnancy (implantation) has occurred. Levonorgestrel works by preventing ovulation or fertilization from occurring. It decreases the chances of pregnancy by 57–93%. In an intrauterine device (IUD), such as Mirena among others, it is effective for the long-term prevention of pregnancy. A levonorgestrel-releasing implant is also available in some countries.

Extended or continuous cycle combined oral contraceptive pills are a packaging of combined oral contraceptive pills (COCPs) that reduce or eliminate the withdrawal bleeding that would occur once every 28 days in traditionally packaged COCPs. It works by reducing the frequency of the pill-free or placebo days. Extended cycle use of COCPs may also be called menstrual suppression, although other hormonal medications or medication delivery systems may also be used to suppress menses. Any brand of combined oral contraceptive pills can be used in an extended or continuous manner by simply discarding the placebo pills; this is most commonly done with monophasic pills in which all of the pills in a package contain the same fixed dosing of a synthetic estrogen and a progestin in each active pill.

<span class="mw-page-title-main">Desogestrel</span> Medication

Desogestrel is a progestin medication which is used in birth control pills. It is also used in the treatment of menopausal symptoms in women. The medication is available and used alone or in combination with an estrogen. It is taken by mouth.

<span class="mw-page-title-main">Drospirenone</span> Medication drug

Drospirenone is a progestin and antiandrogen medication which is used in birth control pills to prevent pregnancy and in menopausal hormone therapy, among other uses. It is available both alone under the brand name Slynd and in combination with an estrogen under the brand name Yasmin among others. The medication is an analog of the drug spironolactone. Drospirenone is taken by mouth.

<span class="mw-page-title-main">Norethisterone acetate</span> Chemical compound

Norethisterone acetate (NETA), also known as norethindrone acetate and sold under the brand name Primolut-Nor among others, is a progestin medication which is used in birth control pills, menopausal hormone therapy, and for the treatment of gynecological disorders. The medication available in low-dose and high-dose formulations and is used alone or in combination with an estrogen. It is ingested orally.

<span class="mw-page-title-main">Norgestrel</span> Progestin medication used for birth control

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<span class="mw-page-title-main">Estrogen patch</span> Transdermal delivery system for estrogens

An estrogen patch, or oestrogen patch, is a transdermal delivery system for estrogens such as estradiol and ethinylestradiol which can be used in menopausal hormone therapy, feminizing hormone therapy for transgender women, hormonal birth control, and other uses. Transdermal preparations of estrogen are metabolized differently than oral preparations. Transdermal estrogens avoid the first pass through the liver and thus potentially reduce the risk of blood clotting and stroke.

Intermenstrual bleeding (IMB) is vaginal bleeding at irregular intervals between expected menstrual periods. It may be associated with bleeding with sexual intercourse.

<span class="mw-page-title-main">Hormonal contraception</span> Birth control methods that act on the endocrine system

Hormonal contraception refers to birth control methods that act on the endocrine system. Almost all methods are composed of steroid hormones, although in India one selective estrogen receptor modulator is marketed as a contraceptive. The original hormonal method—the combined oral contraceptive pill—was first marketed as a contraceptive in 1960. In the ensuing decades, many other delivery methods have been developed, although the oral and injectable methods are by far the most popular. Hormonal contraception is highly effective: when taken on the prescribed schedule, users of steroid hormone methods experience pregnancy rates of less than 1% per year. Perfect-use pregnancy rates for most hormonal contraceptives are usually around the 0.3% rate or less. Currently available methods can only be used by women; the development of a male hormonal contraceptive is an active research area.

<span class="mw-page-title-main">Norethisterone</span> Progestin medication

Norethisterone, also known as norethindrone and sold under many brand names, is a progestin medication used in birth control pills, menopausal hormone therapy, and for the treatment of gynecological disorders. The medication is available in both low-dose and high-dose formulations and both alone and in combination with an estrogen. It is used by mouth or, as norethisterone enanthate, by injection into muscle.

<span class="mw-page-title-main">Dienogest</span> Chemical compound

Dienogest, sold under the brand name Visanne among others, is a progestin medication which is used in birth control pills and in the treatment of endometriosis. It is also used in menopausal hormone therapy and to treat heavy periods. Dienogest is available both alone and in combination with estrogens. It is taken by mouth.

<span class="mw-page-title-main">Medroxyprogesterone acetate</span> Injectable form of birth control

Medroxyprogesterone acetate (MPA), also known as depot medroxyprogesterone acetate (DMPA) in injectable form and sold under the brand name Depo-Provera among others, is a hormonal medication of the progestin type. It is used as a method of birth control and as a part of menopausal hormone therapy. It is also used to treat endometriosis, abnormal uterine bleeding, paraphilia, and certain types of cancer. The medication is available both alone and in combination with an estrogen. It is taken by mouth, used under the tongue, or by injection into a muscle or fat.

<span class="mw-page-title-main">Nomegestrol acetate</span> Chemical compound

Nomegestrol acetate (NOMAC), sold under the brand names Lutenyl and Zoely among others, is a progestin medication which is used in birth control pills, menopausal hormone therapy, and for the treatment of gynecological disorders. It is available both alone and in combination with an estrogen. NOMAC is taken by mouth. A birth control implant for placement under the skin was also developed but ultimately was not marketed.

Progestogen-only injectable contraceptives (POICs) are a form of hormonal contraception and progestogen-only contraception that are administered by injection and providing long-lasting birth control. As opposed to combined injectable contraceptives, they contain only a progestogen without an estrogen, and include two progestin preparations:

<span class="mw-page-title-main">Combined hormonal contraception</span> Form of hormonal contraception combining both an estrogen and a progestogen

Combined hormonal contraception (CHC), or combined birth control, is a form of hormonal contraception which combines both an estrogen and a progestogen in varying formulations.

Menstrual suppression refers to the practice of using hormonal management to stop or reduce menstrual bleeding. In contrast to surgical options for this purpose, such as hysterectomy or endometrial ablation, hormonal methods to manipulate menstruation are reversible.

Hormonal oral contraceptives are preventive medications taken orally to avoid pregnancy in sexually active active females by manipulating their sex hormones. The first oral contraceptive was approved by the FDA and sold to the market in 1960. There are two types of hormonal oral contraceptives, namely Combined Oral Contraceptives and Progesterone Only Pills. Oral contraceptives, be it combined or progesterone-only, can effectively prevent pregnancy by regulating hormonal changes in the menstrual cycle, inhibiting ovulation, and altering cervical mucus to impede sperm mobility; combined pills have extra effects in menstrual cycle regulation and menstrual pain relief. Common off-label uses include menstrual suppression and acne relief, with Combined Oral Contraceptives having additional benefits in relieving menstrual migraine.

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