Androgen Restored Contraceptive

Alternative Name: ARC; triple hormone contraceptive; Triple OC

Description: Androgen restored contraceptive consists of prasterone, estradiol, and progesterone. By adding the natural human androgen dehydroepiandrosterone (DHEA) to an oral contraceptive (OC), the developers anticipate to minimize subjective side effects such as mood changes, decrease of sexual desire, and risk of venous thromboembolic events. Addition of a suitable formulation and dose of DHEA normalizes testosterone (T) levels during OC use and is expected to counteract the clinical consequences of T-deficiency.

Product Details

User: Female

Hormonal: Yes

Delivery Method: Oral

Duration Type: Short-acting

Duration: One day

Regimen:
  • One pill per day

Active Pharmaceutical Ingredient (API):
  • prasterone
  • estradiol
  • progestin

Multipurpose Preventive Technology (MPT): No

Status Details

Developer: ANI Pharmaceuticals, Pantarhei Bioscience

Project Phase: Pre-Clinical and Clinical Development

Development Stage: Phase II

Active Development: Yes

Status Details:
  • A phase II trial to test efficacy and safety has been completed.

Additional Information

References:
  • Zimmerman Y. et al. (2015) Restoring testosterone levels by adding dehydroepiandrosterone to a drospirenone containing combined oral contraceptive. Contraception. 91(2) 127-142.

  • Coelingh Bennink HJT, et al. (2017) Maintaining physiological testosterone levels by adding dehydroepiandrosterone to combined oral contraceptives: I. Endocrine effects. Contraception. 96(5); 322-329.

  • Pantarhei Bioscience website: www.pantarheibio.com/pipeline/androgen-restored-contraception/

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