Phase 3
Completed N=110
Effects on Bone Mineral Density (BMD) of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing LNG/EE (292005)(P05765)(COMPLETED)
Source: ClinicalTrials.gov NCT00511342 ↗Enrolled (actual)
110
Serious AEs
1.8%
Results posted
Aug 2011
Primary outcomePrimary: Mean Change From Baseline in Z-scores of the Lumbar Spine (L2-L4) and Femoral Neck — 0.019; 0.121; -0.007; 0.044 score on a scale — p=0.19
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Z-scores of the Lumbar Spine (L2-L4) and Femoral Neck |
0.019; 0.121; -0.007; 0.044 | 0.19 |
| SECONDARY Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) |
0.000; 1.734 | — |
| SECONDARY Number of Participants With an Occurrence of Breakthrough Bleeding/ Spotting |
22; 14; 12; 6; 15; 3 | — |
| SECONDARY Number of Participants With an Occurrence of Absence of Withdrawal Bleeding |
4; 2; 9; 2; 9; 1 | — |
| SECONDARY Number of Participants With an Occurrence of Breakthrough Bleeding |
6; 1; 2; 1; 2; 1 | — |
| SECONDARY Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) |
17; 13; 10; 5; 14; 2 | — |
| SECONDARY Number of Participants With an Occurrence of Early Withdrawal Bleeding |
5; 7; 3; 4; 3; 3 | — |
| SECONDARY Number of Participants With an Occurrence of Continued Withdrawal Bleeding |
10; 24; 14; 19; 14; 17 | — |
| SECONDARY Average Number of Breakthrough Bleeding-Spotting Days |
4.1; 2.2; 3.8; 4.8; 4.1; 4.0 | — |
| SECONDARY Average Number of Withdrawal Bleeding-spotting Days |
4.7; 6.7; 4.7; 5.3; 4.4; 5.2 | — |
Eligibility Criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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);
- systemic or inhaled administration of corticosteroids (also past use for more than one year, less than five years ago or any period of time in the past year is a contraindication);
- thiazide diuretics;
- thyroid hormone;
- bisphosphonates;
- calcium supplementation in combination with vitamin D supplementation/
calcitonin;
- ever treatment after childhood with fluorides;
- Contraindications for contraceptive steroids
- An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia[CIN], squamous intraepithelial lesion [SIL], carcinoma in situ, invasive carcinoma) at screening;
- Clinically relevant abnormal laboratory result at screening as judged by the investigator;
- Use of an injectable hormonal method of contraception; within 6 months of an injection with a 3-month duration, within 4 months of an injection with a 2-month duration, within 2 months of an injection with a 1-month duration;
- Within 12 months after a pregnancy prior to the start of trial medication;
- Breastfeeding or within 12 months after stopping breastfeeding prior to the start of trial medication;
- Present use or use within 2 months prior to the 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 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.
Data sourced from ClinicalTrials.gov (NCT00511342). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.