A Study to Evaluate Ovarian Follicular Activity and Hormone Levels for DR-102 Compared to Two 28-Day Oral Contraceptives

A Multicenter, Open-Label Study to Evaluate Ovarian Follicular Activity and Hormone Levels With the Oral Contraceptive Regimen DR-102 Compared to Two 28-day Oral Contraceptive Regimens Containing Different Synthetic Progestins

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01291004

Enrollment

206

Registered

2011-02-07

Start date

2011-01-31

Completion date

2012-03-31

Last updated

2021-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Follicle Count, Follicle Development, Follicle Size, Oral Contraceptive, Ovarian Follicle

Brief summary

This study is being conducted to evaluate the impact of a 28-day oral contraceptive compared to two 28-day oral contraceptive regimens containing different synthetic progestins on ovarian follicular activity and hormone levels in healthy women.

Interventions

DRUGDesogestrel/ethinyl estradiol and ethinyl estradiol

Desogestrel/ethinyl estradiol 0.15/0.02 mg and ethinyl estradiol 0.01 mg tablet

DRUG28-day drospirenone oral contraceptive

Drospirenone/ethinyl estradiol 0.3/0.02 mg

DRUG28-day levonorgestrel oral contraceptive

Levonorgestrel/ethinyl estradiol 0.1/0.02 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

* Premenopausal, non-pregnant, non-lactating women age 18-35 years old * Body Mass Index (BMI) ≥18 kg/m² and \<30 kg/m² * Regular spontaneous menstrual cycle * Others as dictated by Food and Drug Administration (FDA)-approved protocol

Exclusion criteria

* Any condition which contraindicates the use of combination oral contraceptives * Known thrombophlebitis or thromboembolic disorders; known or suspected clotting disorders; thrombogenic valvulopathies or rhythm disorders * Migraine headaches with focal, neurological symptoms * Others as dictated by FDA-approved protocol

Design outcomes

Primary

Measure	Time frame
Evaluation of ovarian follicular development by the Hoogland and Skouby grading scale from baseline to week 16.	16 weeks
Change in serum Estradiol level from baseline to week 16.	16 weeks
Change in serum Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) levels from baseline to week 16.	16 weeks
Change in serum Progesterone level from baseline to week 20.	20 weeks

Secondary

Measure	Time frame
Change from baseline to week 15 in D-dimer.	15 weeks
Change from baseline to week 15 in Plasminogen, Factor II, Factor VII, Factor VIII, Protein C, and Free and Total Protein S.	15 weeks
Change from baseline to week 15 in Tissue Plasminogen Activator (t-PA).	15 weeks
Change from baseline to week 15 in Antithrombin.	15 weeks
Change from baseline to end of week 15 in Plasmin-Antiplasmin complex	15 weeks
Change from baseline to week 15 in Total Cortisol and Corticosteroid Binding Globulin (CBG).	15 weeks
Change from baseline to week 15 in Thyroid Stimulating Hormone (TSH).	15 weeks
Change from baseline to week 15 in Sex Hormone Binding Globulin (SHBG).	15 weeks
Return to ovulation rate at week 20.	Week 20
Change from baseline to week 15 in Tissue Factor Pathway Inhibitor (TFPI).	15 weeks
Change from baseline to week 15 in APTT and ETP based activated protein-C resistance (APC).	15 weeks
Change from baseline to week 15 in Fibrinogen.	15 weeks
Change from baseline to week 15 in Prothrombin fragment 1 + 2 levels.	15 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026