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Completed

NCT Number: NCT01291004

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

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.

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Key information

Conditions

Follicle Development Follicle Count Follicle Size Oral Contraceptive Ovarian Follicle

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Teva Investigational Site 10119, Philadelphia, Pennsylvania, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

desogestrel/ethinyl estradiol and ethinyl estradiol

Drug

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

28-day drospirenone oral contraceptive

Drug

Drospirenone/ethinyl estradiol 0.3/0.02 mg

28-day Levonorgestrel Oral Contraceptive

Drug

Levonorgestrel/ethinyl estradiol 0.1/0.02 mg

Primary outcomes

  1. Evaluation of ovarian follicular development by the Hoogland and Skouby grading scale from baseline to week 16.

    Time frame: 16 weeks

  2. Change in serum Estradiol level from baseline to week 16.

    Time frame: 16 weeks

  3. Change in serum Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) levels from baseline to week 16.

    Time frame: 16 weeks

  4. Change in serum Progesterone level from baseline to week 20.

    Time frame: 20 weeks

Secondary outcomes

  1. Change from baseline to week 15 in Prothrombin fragment 1 + 2 levels.

    Time frame: 15 weeks

  2. Change from baseline to week 15 in D-dimer.

    Time frame: 15 weeks

  3. Change from baseline to end of week 15 in Plasmin-Antiplasmin complex

    Time frame: 15 weeks

  4. Change from baseline to week 15 in APTT and ETP based activated protein-C resistance (APC).

    Time frame: 15 weeks

  5. Change from baseline to week 15 in Fibrinogen.

    Time frame: 15 weeks

  6. Change from baseline to week 15 in Plasminogen, Factor II, Factor VII, Factor VIII, Protein C, and Free and Total Protein S.

    Time frame: 15 weeks

  7. Change from baseline to week 15 in Tissue Plasminogen Activator (t-PA).

    Time frame: 15 weeks

  8. Change from baseline to week 15 in Antithrombin.

    Time frame: 15 weeks

  9. Change from baseline to week 15 in Tissue Factor Pathway Inhibitor (TFPI).

    Time frame: 15 weeks

  10. Change from baseline to week 15 in Total Cortisol and Corticosteroid Binding Globulin (CBG).

    Time frame: 15 weeks

  11. Change from baseline to week 15 in Thyroid Stimulating Hormone (TSH).

    Time frame: 15 weeks

  12. Change from baseline to week 15 in Sex Hormone Binding Globulin (SHBG).

    Time frame: 15 weeks

  13. Return to ovulation rate at week 20.

    Time frame: Week 20

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 7, 2011
Registry last updated
Dec 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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