• Disease Overview
  • Synonyms
  • Signs & Symptoms
  • Causes
  • Affected Populations
  • Disorders with Similar Symptoms
  • Diagnosis
  • Standard Therapies
  • Clinical Trials and Studies
  • References
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Progestogen Hypersensitivity

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Last updated: 8/8/2024
Years published: 2024


Acknowledgment

NORD gratefully acknowledges Gioconda Alyea, MD (FMG), MS, National Organization for Rare Disorders for assistance in the preparation of this report.


Disease Overview

Progestogen hypersensitivity (PH) is a condition where the body has an allergic reaction to progesterone, a hormone produced by the ovaries, or to synthetic forms of progesterone called progestins, which are often used in birth control or fertility treatments.1,2 The presentation of PH is varied and can start at any time from the first period (menarche) to menopause in reproductive aged women.3

PH can cause a variety of symptoms including:1,3

  • Skin reactions which include dermatitis (skin inflammation), urticaria (hives) and other rashes
  • Respiratory issues such as wheezing due to bronchospasm (narrowing of the airways) and asthma
  • Severe allergic reactions that can be life threatening (anaphylaxis) in rare cases

PH can be classified as: 4

  • Endogenous PH: Symptoms occur during the luteal phase of the menstrual cycle, which is the second half of the cycle when progesterone levels are naturally higher (about one week before menstruation starts).
  • Exogenous PH: Symptoms appear after exposure to synthetic progestins, such as those in contraceptives or fertility medications.

The timing of symptoms is important for diagnosing PH. The main diagnostic tests are progesterone skin tests and progestogen challenge if PH from synthetic progestins is suspected, which involves administering a small amount of progestin and monitoring for a reaction.4

Treatment depends on the specific symptoms each affected person has and may include medication to treat symptoms such as antihistamines for skin reactions or bronchodilators for asthma, medications to stop ovulation and reduce progesterone production and progesterone desensitization, which consist of gradually increasing exposure to progesterone under medical supervision to reduce sensitivity.1,4

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Synonyms

  • autoimmune progesterone dermatitis
  • progesterone allergy
  • progesterone hypersensitivity
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Signs & Symptoms

Progestogen hypersensitivity (PH) symptoms can vary widely. These symptoms often occur in a cyclical pattern in women, appearing during the second half of the menstrual cycle (luteal phase) when progesterone levels are naturally higher. However, the onset of symptoms triggered by exposure to exogenous progesterone (after an assisted fertilization procedure, after the use of exogenous progestogens (contraceptives) or after using other types of steroids) is not necessarily related to the menstrual cycle.1,3

Symptoms may include:1

  • Skin symptoms: Rash, hives (urticaria), eczema, genital inflammation and in severe cases, conditions like Stevens-Johnson syndrome
    • Lesions are usually symmetrical and occur on the face, trunk and extremities
    • Affected women often feel itchy, and some have systemic symptoms such as chest tightness, shortness of breath and anaphylactic reaction
    • Inflammation in the mucous lining of the mouth (stomatitis) and mucosal lesions are less common
    • Ruptured blisters leading to crusting and thick raised lighted scars
  • Respiratory symptoms: Wheezing and asthma-like symptoms
  • Systemic symptoms: Severe allergic reactions such as anaphylaxis
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Causes

The exact cause of progestogen hypersensitivity is not well understood but several theories exist:1,4

  • Immediate allergic reaction, where the synthetic progestogens can trigger a type 1 hypersensitivity reaction. This means the body forms antibodies specifically against progesterone, leading to an allergic response.
  • Delayed allergic reaction, where it is believed that PH may involve a type 4 hypersensitivity reaction, where symptoms develop more slowly after exposure to progestogens
  • Autoimmune response, where the affected people develop an ongoing autoimmune response to their own progesterone, particularly during the luteal phase of their menstrual cycle when progesterone levels are highest

For affected people with no prior exposure to synthetic progestogens, the cause of PH remains unclear.

Based on the cause, PH can be classified as:4

  • Endogenous PH: Symptoms occur during the luteal phase of the menstrual cycle which is the second half of the cycle when progesterone levels are naturally higher (about one week before the menstruation starts).
  • Exogenous PH: Symptoms appear after exposure to synthetic progestins, such as those in contraceptives or fertility medications.

Progesterone levels vary throughout life, with the greatest variations during puberty and levels also change during the menstrual cycle (period) in response to the pulsatile secretion of follicle stimulating hormone (or FSH) and luteinizing hormone (or LH) by the pituitary gland, located in the brain. Progesterone levels are considerably higher in women than in men.5,6

During a period (the menstrual cycle), progesterone levels rise just before ovulation and peak during the “luteal phase” around day 21 of a 28-day menstrual cycle, generally one week prior to the start of menstruation. Progesterone is initially made by the ovarian structure known as the corpus luteum and has an important role in preparing the uterus for pregnancy. If pregnancy does not occur, the corpus luteum will regress and the progesterone levels drop. The progesterone drop will trigger menstruation.5,6 Symptoms of endogenous PH typically develop during the luteal phase.

If pregnancy does occur, progesterone levels rise throughout the pregnancy and remain high throughout pregnancy. After a baby is born, there is a rapid decrease in the progesterone levels in blood.5,6

Pregnancy can either trigger, worsen, or improve PH symptoms. When PH starts during pregnancy, the symptoms may continue or resolve after childbirth.

Symptom relief during pregnancy might be due to the gradual increase in progesterone levels or a reduction in the maternal immune response.

PH can also begin after childbirth, suggesting that high levels of progesterone during pregnancy might sensitize some women to the hormone.

Symptoms from synthetic progestogens (used in contraception or fertility treatments) as commented before, are usually related with exposure to these substances and are not tied to the luteal phase of the menstrual cycle. Various synthetic progestins can trigger PH symptoms, including:1

  • Oral contraceptive pills
  • Long-acting depot progestin injections
  • Contraceptive vaginal rings
  • Progestin-containing intrauterine devices (IUDs)
  • High doses of progesterone used to support pregnancy in patients undergoing in vitro fertilization (IVF)
  • Corticosteroids that are structurally similar to progesterone.
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Affected populations

PH appears to be rare, with fewer than 200 reported cases, although it may be under-recognized, and there are no published estimates of incidence or prevalence.

PH predominantly affects women of reproductive age, with an average age of onset in the late 20s among patients described in the medical literature. There is a single reported case of hypersensitivity in a male patient receiving the progestin, megestrol acetate. PH was reported in very few postmenopausal women treated with progestins as part of hormone replacement therapy (HRT), as the symptoms typically disappear after menopause.3,4

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Diagnosis

Diagnosing progestogen hypersensitivity (PH) can be difficult due to the variety of symptoms and their cyclical nature.5

A detailed medical history particularly focusing on any use of synthetic progestogens, such as birth control pills, progestin injections, vaginal rings, or intrauterine devices is very important, as well as noting when symptoms occur in relation to the menstrual cycle can provide important clues for the diagnosis.5 This helps to rule out other diagnoses and shows a clear link between symptoms and exposure to progestogens.

Progesterone skin testing can be done, but it is not always reliable. An allergist may also consider a progestogen challenge, where a small amount of progestin is given under medical supervision to see if it triggers symptoms.5

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Standard Therapies

As progestogen hypersensitivity is a rare condition it is often mistaken for other skin diseases. Many affected people are first treated with antihistamines and glucocorticoids, which can sometimes improve symptoms. However, the main approach to treatment involves suppressing ovulation and reducing progesterone levels, especially during the luteal phase of the menstrual cycle.

Treatment for progestogen hypersensitivity (PH) varies depending on the individual’s symptoms and their severity, and it may involve:1,2

  • Symptom management using medications to treat specific symptoms such as antihistamines for skin reactions or bronchodilators for respiratory symptoms
  • Ovulation suppression medications that stop ovulation, reduce progesterone production and alleviate symptoms. These medications include:
    • Contraceptive pills
    • Dermal embedding, a contraceptive device implanted below the skin that slowly releases progesterone to inhibit ovulation with fewer side effects than oral contraceptives
  • Progesterone desensitization to gradually increase exposure to progesterone under medical supervision to reduce the body’s sensitivity

 

Other treatment options that have being used with some success include: 8

 

  • Tamoxifen given in combination with ovarian suppressing medication
  • Intramuscular and intranasal gonadotropin-releasing hormone (GnRH) agonists that inhibit ovulation, but are not recommended for long-term use (typically less than six months) due to side effects
  • 17-a-alkylated steroids that suppress pituitary-hypothalamic response and interfere with hormone receptors
  • Glucocorticoids used in combination with other drugs to manage symptoms
  • Surgical removal of the ovaries to eliminate progesterone production
  • Estrogen preparations that can suppress ovulation and reduce progesterone levels
  • Omalizumab, usually used for severe allergic asthma and chronic spontaneous urticaria

Some women with PH may experience changes in their symptoms during pregnancy, with some finding relief and others experiencing worsening symptoms. Symptoms disappear in menopause.

Progestogen hypersensitivity is a condition where some people react badly to certain hormones, which can make daily life very difficult. To figure out what’s going on, it’s important for a patient to keep track of when and how symptoms appear and to share their complete medical history with their doctor. More studies are needed to learn why this happens, how to diagnose it more accurately and how to treat it better.

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Clinical Trials and Studies

Information on current clinical trials is posted on the Internet at www.clinicaltrials.gov. All studies receiving U.S. government funding, and some supported by private industry, are posted on this government web site.

For information about clinical trials being conducted at the NIH Clinical Center in Bethesda, MD, contact the NIH Patient Recruitment Office:

Toll-free: (800) 411-1222
TTY: (866) 411-1010
Email: [email protected]

Some current clinical trials also are posted on the following page on the NORD website: https://rarediseases.org/living-with-a-rare-disease/find-clinical-trials/

For information about clinical trials sponsored by private sources, in the main, contact: www.centerwatch.com

For more information about clinical trials conducted in Europe, contact: https://www.clinicaltrialsregister.eu/

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References

  1. Chiarella SE, Buchheit KM, Foer D. Progestogen hypersensitivity. J Allergy Clin Immunol Pract. 2023 Dec;11(12):3606-3613.e2. https://pubmed.ncbi.nlm.nih.gov/37579875/
  2. Buchheit KM & Bernstein JA. Progestogen hypersensitivity. UpToDate. May 16, 2024. https://www.uptodate.com/contents/progestogen-hypersensitivity Accessed August 8, 2024.
  3. Foer D, Buchheit KM. Presentation and natural history of progestogen hypersensitivity. Ann Allergy Asthma Immunol. 2019 Feb;122(2):156-159. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6497082/
  4. Bolaji II, O’Dwyer EM. Post-menopausal cyclic eruptions: autoimmune progesterone dermatitis. Eur J Obstet Gynecol Reprod Biol. 1992 Nov 19;47(2):169-71. https://pubmed.ncbi.nlm.nih.gov/1459332/
  5. Alonso Bello CD, González Guzmán OP, Moncayo Coello CV, Rojo Gutiérrez MI, Castrejón Vázquez MI. Diagnostic tests for progestogen hypersensitivity. Front Allergy. 2024 Apr 24;5:1384140. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11076683/
  6. The menstrual cycle. Patient Education UCS Health. https://www.ucsfhealth.org/education/the-menstrual-cycle Accessed August 8, 2024.
  7. Chronic Spontaneous/Idiopathic Urticaria (Chronic hives). American College of Allergy, Asthma and Immunology. https://acaai.org/allergies/allergic-conditions/skin-allergy/chronic-hives/ Accessed August 8, 2024.
  8. Huang Y, Ye S, Bao X, Yang R, Huang J. Whole course of treatment of autoimmune progesterone dermatitis that had spontaneously resolved during pregnancy: A case report and review of the literature. Front Immunol. 2022 Sep 7;13:939083. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9490548/
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