Ovulation Incidence in Oral Contraceptive Users

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT03106454
Phase
PHASE3
Status
Completed

Conditions

  • Contraception
  • Ovulation

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Ethinyl Estradiol, Norethindrone acetate, ferrous fumarate — DRUG
    Combination Oral Contraceptive Pill. Ethinyl Estradiol 10mcg/Norethindrone acetate 1mg/ferrous fumarate 75mg
  • Norethindrone — DRUG
    Norethindrone 1.05mg

Study Details

Since the introduction of the combined hormonal contraceptive pill, dosages of ethinyl estradiol (EE) have steadily decreased from more than 150mcg to 20mcg in an attempt to improve the risk profile associated with the COC. In 2010, the Food and Drug Administration approved a oral contraceptive pill containing EE 10mcg/NET acetate 1mg (Tradename Lo loestrin). However, no studies have compared this formulation to pills containing either higher doses of estrogen or progestin alone. It is not known whether EE 10mcg is sufficient to prevent follicular development or to support the endometrium as well as higher doses of EE. This trial addresses the question of whether an oral contraceptive pill with EE 10mcg/Norethindrone acetate 1mg will better suppress ovulation or have a better side effect profile than a progestin only pill with a nearly equal dose of norethindrone.

Key Dates

Start date
Aug 31, 2014
Status verified
Dec 2025
Primary completion
Jan 31, 2024
Completion
Jan 1, 2024

Study Design

Enrollment
58 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Combination oral contraceptive pill
    Ethinyl Estradiol 10mcg/Norethindrone acetate 1mg/ferrous fumarate 75mg Taken cyclically as 24 tablets containing EE 10mcg/NET acetate 1mg 2 tablets of EE 10mcg only 2 tablets of ferrous fumarate 75mg
  • Experimental: Progestin only pill
    Norethindrone 0.35mg Marketed use for 1 tablet per day. For study dosing, patients will take 3 tablets daily for a total of 1.05mg daily.

Primary Outcome Measure

Ovulation [ Time Frame: A single 28 day cycle ]

Locations (1)

FacilityCityStateZIPSite coordinators
Brian T. NguyenLos AngelesCalifornia90065-

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By research site
Brian T. Nguyen· Los Angeles, CA

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