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Completed

NCT Number: NCT00511433

Effects on Ovarian Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292003)(COMPLETED)(P05723)

The primary purpose of this study is to evaluate the effects of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) on ovarian function.

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Key information

Conditions

Contraception

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Willing to use COC for at least 6 cycles.
  • 18 - 35 years of age at screening.
  • Body Mass Index (BMI) of >/= 17 and </= 35.
  • Good physical and mental health.
  • Willing to use condoms as the sole contraceptive method during screening cycle and 1 post-treatment cycle.
  • Willing to give informed consent.

Exclusion criteria

  • Contraindications for contraceptive steroids (general).
  • Additional contraindications (renal, hepatic or adrenal insufficiency).
  • Breastfeeding.
  • Present use (or use within 2 months prior to start of the trial medication) of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex

steroids (other than pre- and post treatment contraceptive method) and herbal remedies containing Hypericum perforatum (St. John's Wort).

  • Administration of any other investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period.
  • Abnormal cervical smear at screening, or documentation of an abnormal smear performed within 6 months before screening.
  • Clinically relevant abnormal laboratory result at screening as judged by the investigator.

Treatment and study plan

NOMAC-E2

Drug

Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28

for 6 consecutive 28-day menstrual cycles.

DRSP-EE

Drug

Drospirenone and Ethinyl Estradiol Tablets, 3 mg DRSP and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day menstrual cycles.

Primary outcomes

  1. Effect on Ovarian Function as Determined by the Number of Participants With an Occurrence of Ovulation

    Time frame: Cycle 1, Cycle 2, and Cycle 6

    During treatment, ovulation was assessed for each participant by the investigator on the basis of ultrasound scanning (USS). The final analysis was based on assessor-blind adjudication.

  2. Effect on Ovarian Function as Determined by the Maximum Follicle Diameter

    Time frame: Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6

    The maximum follicular diameter was defined as the largest follicular diameter during a treatment cycle.

  3. Effect on Ovarian Function as Determined by the Maximum Progesterone Value

    Time frame: Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6

    The maximum progesterone value was defined as the largest value during a cycle.

  4. Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2)

    Time frame: Cycle 1, Cycle 2, Cycle 3, and Cycle 6

    The parameter was measured at pre-defined study days.

  5. Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH)

    Time frame: Cycle 1, Cycle 2, Cycle 3, and Cycle 6

    The parameter was measured at pre-defined study days.

  6. Effect on Ovarian Function as Determined by Luteinizing Hormone (LH)

    Time frame: Cycle 1, Cycle 2, Cycle 3, and Cycle 6

    The parameter was measured at pre-defined study days.

Secondary outcomes

  1. Effect on Cervical Mucus as Determined by Insler Score

    Time frame: Screening Cycle, Cycle 1, Cycle 2, and Cycle 7 (post-treatment cycle)

    The Insler Score was assessed on Day 6 after ovulation during the Screening Cycle, on Day 21 of Cycle 1, and when the maximum follicle diameter was greater than or equal to 15 mm. The Insler Score consisted of four categories each scaled from 0 (none) to 3 (complete). The higher the score, the greater the cervical reaction.

  2. Effect on Maximum Endometrial Thickness

    Time frame: Screening Cycle, Cycle 1, Cycle 2, and Cycle 6

    Maximum endometrial thickness was defined as the largest endometrial thickness during a cycle.

  3. Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)

    Time frame: 6 cycles

    In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of two days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 woman years) that the women were under risk of becoming pregnant.

  4. Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting

    Time frame: Every 28-day cycle for 6 cycles

    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the "expected non-bleeding period" that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.

  5. Number of Participants With an Occurrence of Absence of Withdrawal Bleeding

    Time frame: Every 28-day cycle for 6 cycles

    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the "expected bleeding period". Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.

  6. Number of Participants With an Occurrence of Breakthrough Bleeding

    Time frame: Every 28-day cycle for 6 cycles

    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the "expected non-bleeding period" that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2:21-day period starting on Day 4 of the cycle.

  7. Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)

    Time frame: Every 28-day cycle for 6 cycles

    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the "expected non-bleeding period" that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2:21-day period starting on Day 4 of the cycle.

  8. Number of Participants With an Occurrence of Early Withdrawal Bleeding

    Time frame: Every 28-day cycle for 6 cycles

    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current "expected bleeding period". Expected bleeding period: DRSP-EE: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.

  9. Number of Participants With an Occurrence of Continued Withdrawal Bleeding

    Time frame: Every 28-day cycle for 5 cycles

    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the "expected non-bleeding period" of the next cycle. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.

  10. Average Number of Breakthrough Bleeding/Spotting Days

    Time frame: Every 28-day cycle for 6 cycles

    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the "expected non-bleeding period" that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.

  11. Average Number of Withdrawal Bleeding Days

    Time frame: Every 28-day cycle for 6 cycles

    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding was defined as bleeding/spotting episode that started during or continued into the "expected bleeding period". Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Randomized, Open-Label, Comparative Trial to Evaluate the Effects on Ovarian Function of a Monophasic Combined Oral Contraceptive (COC) Containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2), Compared to a Monophasic COC Containing 3 mg Drospirenone (DRSP) and 30 ug Ethinyl Estradiol (EE)

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Aug 3, 2007
Registry last updated
Feb 9, 2022

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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