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

Can Drospirenone be Used to Prevent LH Surge in Controlled Ovarian Stimulation in PCOS?!

Phase 1
Completed
Conditions
PCOS (Polycystic Ovary Syndrome)
Interventions
First Posted Date
2024-09-23
Last Posted Date
2025-01-22
Lead Sponsor
Ahmed Saad
Target Recruit Count
50
Registration Number
NCT06608186
Locations
🇪🇬

Hawaa Fertility center, Banhā, Qalyubiya, Egypt

Drospirenone Only Pills and Cervical Mucus Changes: A Pre- and Post-Bariatric Surgery Study

Not Applicable
Recruiting
Conditions
Contraception
Interventions
First Posted Date
2024-04-03
Last Posted Date
2024-08-14
Lead Sponsor
Chulalongkorn University
Target Recruit Count
16
Registration Number
NCT06345586
Locations
🇹🇭

Chulalongkorn University, Bangkok, Thailand

Pharmacokinetics of Drospirenone Only Pills: A Pre- and Post-Bariatric Surgery Study

Phase 1
Recruiting
Conditions
Contraception
Interventions
First Posted Date
2024-04-03
Last Posted Date
2024-08-14
Lead Sponsor
Chulalongkorn University
Target Recruit Count
16
Registration Number
NCT06345560
Locations
🇹🇭

Chulalongkorn University, Bangkok, Thailand

The Use of Drospirenone/Estetrol, Nomegestrol Acetate/Estradiol and Ethinylestradiol/Dienogest in Random Start Rapid Endometrial Preparation

Phase 4
Completed
Conditions
Endometrial Polyp
Endometrial Diseases
Interventions
First Posted Date
2024-03-22
Last Posted Date
2024-04-08
Lead Sponsor
University of Palermo
Target Recruit Count
150
Registration Number
NCT06324851
Locations
🇮🇹

Andrea Etrusco, Palermo, Italy

🇮🇹

Marco Monti, Rome, Italy

Evaluate the Pharmacokinetics of a Combined Oral Contraceptive (COC) With and Without Obicetrapib

First Posted Date
2024-02-08
Last Posted Date
2024-02-15
Lead Sponsor
NewAmsterdam Pharma
Target Recruit Count
30
Registration Number
NCT06250205
Locations
🇺🇸

NOVUM, Las Vegas, Nevada, United States

Evaluation of the Efficacy and Safety of Drospirenone in the Treatment of Adenomyosis

Not yet recruiting
Conditions
Adenomyosis
First Posted Date
2023-12-18
Last Posted Date
2023-12-18
Lead Sponsor
University of Palermo
Target Recruit Count
40
Registration Number
NCT06174792
Locations
🇮🇹

Andrea Etrusco, Palermo, Italy

A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese

Phase 1
Completed
Conditions
Overweight
Interventions
First Posted Date
2023-09-15
Last Posted Date
2024-07-26
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
46
Registration Number
NCT06039826
Locations
🇺🇸

Qps-Mra, Llc, South Miami, Florida, United States

🇺🇸

ICON Early Phase Services, San Antonio, Texas, United States

Efficacy and Safety of Dingkundan Combined With Combination Oral Contraceptives in the Treatment of PCOS

Not Applicable
Completed
Conditions
PCOS
Interventions
First Posted Date
2023-05-24
Last Posted Date
2024-05-30
Lead Sponsor
Guangdong Women and Children Hospital
Target Recruit Count
120
Registration Number
NCT05872425
Locations
🇨🇳

Guangdong Women and Children Health Hospital, Guangzhou, Guangdong, China

A Study of Milvexian in Healthy Adult Females

Phase 1
Completed
Conditions
Healthy Female
Interventions
First Posted Date
2023-01-31
Last Posted Date
2025-03-30
Lead Sponsor
Janssen Pharmaceutica N.V., Belgium
Target Recruit Count
20
Registration Number
NCT05706753
Locations
🇧🇪

SGS Belgium NV, Edegem, Belgium

Efficacy, Safety, and Tolerability of LPRI-CF113 as an Oral Contraceptive in Females

Phase 3
Active, not recruiting
Conditions
Contraception
Change in Bone Mineral Density
Interventions
First Posted Date
2022-07-18
Last Posted Date
2025-04-03
Lead Sponsor
Insud Pharma
Target Recruit Count
1009
Registration Number
NCT05461573
Locations
🇺🇸

Direct Helpers Research Center, Hialeah, Florida, United States

🇺🇸

Clinohio Research Services, Columbus, Ohio, United States

🇺🇸

Del Sol Research Management, Tucson, Arizona, United States

and more 19 locations
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