Effects on Bone Mineral Density (BMD) of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing LNG/EE (292005)(P05765)(COMPLETED)

NCT00511342 | Completed Phase 3 Results

• 2 other identifiers: P05765Organon Protocol No. 292005
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary purpose of this study is to evaluate the effects of the NOMAC-E2 combined oral contraceptive (COC) on bone mineral density (BMD).

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Z-scores of the Lumbar Spine (L2-L4) and Femoral Neck

  BMD was measured by a Dual Energy X-ray Absorptiometry (DEXA) machine. The Z-score measures the distance of the measured BMD value from the appropriate normal age matched population mean value in units of standard deviation of this population. More negative scores indicate less BMD compared to age matched population, \& more positive scores indicate higher BMD compared to age matched population. The adjusted mean change from baseline to the after Cycle 26 visit of the Z-scores is estimated using a baseline-adjusted analysis of covariance (ANCOVA).

  Baseline and after cycle 26 (2 years)

Secondary Outcomes (9)

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

  2 years (26 cycles)

• Number of Participants With an Occurrence of Breakthrough Bleeding/ Spotting

  Every 28-day cycle for 26 cycles (2 years total)

• Number of Participants With an Occurrence of Absence of Withdrawal Bleeding

  Every 28-day cycle for 26 cycles (2 years total)

• Number of Participants With an Occurrence of Breakthrough Bleeding

  Every 28-day cycle for 26 cycles (2 years total)

• Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)

  Every 28-day cycle for 26 cycles (2 years total)

Study Arms (2)

NOMAC-E2

EXPERIMENTAL

Nomegestrol Acetate (NOMAC) and Estradiol (E2), 2.5 mg NOMAC and 1.5 mg E2 monophasic COC

Drug: NOMAC-E2

LNG-EE

ACTIVE COMPARATOR

Levonorgestrel (LNG) and Ethinyl Estradiol (EE), 0.150 mg LNG and 0.030 mg EE monophasic COC

Drug: LNG-EE

Interventions

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 26 consecutive 28-day menstrual cycles (2 years).

Also known as: SCH 900121

NOMAC-E2

LNG-EE DRUG

Levonorgestrel and Ethinyl Estradiol Tablets, 0.150 mg Levonorgestrel and 0.030 mg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 for 26 consecutive 28-day menstrual cycles (2 years).

Also known as: SCH 900121

LNG-EE

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sexually active women, at risk for pregnancy and not planning to use condoms
• during treatment;
• At least 20 but not older than 35 years of age at the time of screening;
• BMI = 17 and = 35;
• Good physical and mental health;
• Willing to give informed consent in writing;
• Willing to take part in the trial for two years.

You may not qualify if:

• Family history of osteoporotic fracture below the age of 70;
• Postgastrectomy;
• History of eating disorder, viz. anorexia nervosa, bulimia;
• Endocrine disorder (including controlled diabetes, \[para\]thyroid disease, Cushing's disease);
• Rheumatoid arthritis;
• Significant scoliosis;
• Fasting parathyroid hormone (PTH) outside the reference range at screening;
• Fasting calcitonin outside the reference range at screening;
• Prolactin above the reference range (hyperprolactinemia) at screening;
• Fasting cholesterol and/or triglycerides above the reference range for age at screening (treatment with lipid lowering drugs not allowed);
• Engaging in vigorous exercise such as marathon, competitive swimming, triathlon;
• Smoking more than ten cigarettes/day;
• Use of more than two units of alcohol a day;
• Use of one or more of the following drugs:
• gonadotropin releasing hormone (GnRH) analogues (also past use for more than six months at any time, or for any period of time less than six months ago is a contraindication);

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Sordal T, Grob P, Verhoeven C. Effects on bone mineral density of a monophasic combined oral contraceptive containing nomegestrol acetate/17beta-estradiol in comparison to levonorgestrel/ethinylestradiol. Acta Obstet Gynecol Scand. 2012 Nov;91(11):1279-85. doi: 10.1111/j.1600-0412.2012.01498.x. Epub 2012 Aug 21.

  PMID: 22762147 RESULT

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2007
• First Posted: August 3, 2007
• Study Start: September 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: February 9, 2022
• Results First Posted: August 29, 2011

Record last verified: 2022-02