MedPath

Drospirenone

Generic Name
Drospirenone
Brand Names
Angeliq 0.25/0.5 28 Day, Beyaz 28 Day, Gianvi 28-day, Jasmiel 28 Day, Lo-zumandimine 28 Day, Loryna, Nextstellis 28 Day, Nikki 28 Day, Ocella 28 Day, Safyral 28 Day, Slynd, Syeda 28 Day, Tydemy 28 Day, Vestura, Yasmin, Yasmin 28 Day, Yaz 28 Day, Yaz Plus, Zarah, Zumandimine 28 Day
Drug Type
Small Molecule
Chemical Formula
C24H30O3
CAS Number
67392-87-4
Unique Ingredient Identifier
N295J34A25
Background

Drospirenone is a synthetic progestin commonly found in the popular oral contraceptive, Yaz in combination with Ethinyl estradiol. Most recently, it was approved by both Health Canada and the FDA in combination with Estetrol as an oral contraceptive therapy. Aside from its contraceptive effects, drospirenone is used with estrogens to control acne and premenstrual dysphoric disorder (PMDD).

Drospirenone has been the subject of widespread safety concern due to the possibility of an increased risk of venous thromboembolism associated with its use. In 2012, however, a safety statement by the FDA concluded that the increase in the risk of thromboembolism resulting from the use of drospirenone remains unclear, as studies regarding this risk are conflicting. Some studies have demonstrated a significantly increased risk and some demonstrating no risk of thromboembolic events. In its statement, the FDA has mentioned that increased risk of venous thromboembolism with oral contraceptives such as drospirenone exists but remains lower than the risk of this condition during pregnancy and during the postpartum period, and this should be considered when assessing potential risks of hormonal contraceptive use.

Indication

Drospirenone, in combination with ethinyl estradiol or estetrol, is indicated as an oral contraceptive for the prevention of pregnancy. In addition to its use for contraceptive effects, this combination is used to treat moderate acne vulgaris and the symptoms of premenstrual dysphoric disorder. The drug has approved indications for combination with estrogens for the treatment of menopause-associated symptoms, such as vasomotor symptoms and vulvovaginal atrophy. Drospirenone combined with estrogen may also may aid in the prevention of osteoporosis in women who have been post-menopausal for at least a year and are not candidates for other therapies. It can sometimes be found in preparations containing estrogen and folic acid for folic acid replenishment during oral contraception.

When used for the treatment of acne vulgaris, drospirenone-containing contraceptives should only be used in women ≥14 years of age who have experienced menarche, desire oral contraception, and do not have any contraindications to oral contraceptives. Off-label uses for this drug include the treatment of menstrual irregularities, dysmenorrhea, hirsutism, and endometriosis.

Associated Conditions
Atrophy of vulva, Moderate to Severe Vasomotor Symptoms, Neural Tube Defects (NTDs), Premenstrual Dysphoric Disorder (PMDD), Vulvo Vaginal Atrophy, Moderate Acne vulgaris
Associated Therapies
Contraception, Folate supplementation therapy

Aspirin for the Management of Endometriosis-associated Pelvic Pain

Phase 4
Recruiting
Conditions
Pelvic Pain
Interventions
First Posted Date
2021-12-14
Last Posted Date
2022-01-24
Lead Sponsor
Women's Hospital School Of Medicine Zhejiang University
Target Recruit Count
220
Registration Number
NCT05156879
Locations
🇨🇳

Women's Hospital School of Medicine Zhejiang University, Hangzhou, Zhejiang, China

Oral Contraceptives for Treating Premenstrual Dysphoric Disorder in Bipolar Disorder

Phase 2
Recruiting
Conditions
Premenstrual Dysphoric Disorder
Bipolar Disorder
Interventions
Drug: Placebo
First Posted Date
2021-10-28
Last Posted Date
2023-09-08
Lead Sponsor
St. Joseph's Healthcare Hamilton
Target Recruit Count
60
Registration Number
NCT05098574
Locations
🇨🇦

St Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada

Oral Contraceptives as Infertility Treatments for Premature Ovarian Failure

Not Applicable
Conditions
Primary Ovarian Insufficiency
Menopause, Premature
Interventions
First Posted Date
2016-05-02
Last Posted Date
2016-05-02
Lead Sponsor
Navy General Hospital, Beijing
Target Recruit Count
20
Registration Number
NCT02757469
Locations
🇨🇳

Navy General Hospital, Beijing, Beijing, China

Clinical, Metabolic and Endocrine Effects of the Treatment With Drospirenone and Ethinyl Estradiol Alone or in Combination With Myo-inositol in Young Women With Polycystic Ovary Syndrome (PCOS) and Insulin Resistance

Phase 4
Completed
Conditions
PCOS
Polycystic Ovary Syndrome
Interventions
First Posted Date
2012-01-19
Last Posted Date
2012-01-19
Lead Sponsor
AGUNCO Obstetrics and Gynecology Centre
Registration Number
NCT01511822
Locations
🇮🇹

Istituto di Patologia Ostetrica e Ginecologica, Catania, Italy

A Study to Evaluate the Effectiveness of NuvaRing® to Prevent Pregnancies in Chinese Women (P06450)

Phase 3
Completed
Conditions
Contraception
Interventions
Drug: ENG 120 µg + EE 15 µg intravaginal ring
First Posted Date
2011-01-14
Last Posted Date
2024-06-20
Lead Sponsor
Organon and Co
Target Recruit Count
983
Registration Number
NCT01277211

Study to Investigate Compliance With the Oral Contraceptive SH T00186D in a Flexible Extended Regimen Supported by a Dispenser With a Reminder Function

Phase 3
Completed
Conditions
Contraception
Interventions
First Posted Date
2010-12-10
Last Posted Date
2014-10-28
Lead Sponsor
Bayer
Target Recruit Count
508
Registration Number
NCT01257984

A Study to Examine the Safety and Efficacy of Drospirenone and Ethinyl Estradiol (YAZ) Versus Placebo In HS

Phase 2
Terminated
Conditions
Hidradenitis Suppurativa
Interventions
First Posted Date
2008-07-28
Last Posted Date
2014-02-10
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
4
Registration Number
NCT00722800
Locations
🇺🇸

Clinical Unit for Research Trials in Skin, Boston, Massachusetts, United States

Safety and Efficacy Of Drospirenone and Ethinyl Estradiol vs Placebo in the Treatment of Truncal Acne

Phase 3
Completed
Conditions
Acne Vulgaris
Interventions
First Posted Date
2008-07-28
Last Posted Date
2013-03-05
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
30
Registration Number
NCT00722761
Locations
🇺🇸

Clinical Unit for Research Trials in Skin, Boston, Massachusetts, United States

Cycle Control and Safety of E2-DRSP

Phase 2
Completed
Conditions
Contraceptive, Oral, Hormonal
Interventions
Drug: E2/DRSP (BAY 86-4891) dose 1 (SH T04984E)
Drug: E2/DRSP (BAY 86-4891) dose 2 (80458739)
Drug: E2/DRSP (BAY 86-4891) dose 4 (80458720)
Drug: Placebo
Drug: E2/DRSP (BAY 86-4891) dose 3 (80458755)
Drug: E2/DRSP (BAY 86-4891) dose 5 (80458712)
First Posted Date
2008-04-07
Last Posted Date
2015-04-23
Lead Sponsor
Bayer
Target Recruit Count
635
Registration Number
NCT00653614

The Oral Contraceptive Pill for Premenstrual Worsening of Depression

Not Applicable
Completed
Conditions
Premenstrual Syndrome
Depression
Interventions
First Posted Date
2008-03-12
Last Posted Date
2017-03-20
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
32
Registration Number
NCT00633360
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

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