Clinical trial NCT00413062: Efficacy and Safety Study of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292002)(P05722)
Official title: A Randomized, Open-Label, Comparative, Multi -Center Trial to Evaluate Contraceptive Efficacy, Cycle Control, Safety and Acceptability 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 µg Ethinyl Estradiol (EE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2006-12-19
Enrollment: 2281
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) in a large group of women aged 18-50 years.


Eligibility criteria: Inclusion Criteria:

* Sexually active women, at risk for pregnancy and not planning to use condoms;
* Women in need for contraception and willing to use an oral contraceptive (OC) for 12 months (13 cycles);
* At least 18 but not older than 50 years of age at the time of screening;
* Body mass index \>=17 and \<=35;
* Good physical and mental health;
* Willing to give informed consent in writing.

Exclusion Criteria:

* Contraindications for contraceptive steroids
* In accordance with the Summary of Product Characteristics (SmPC)/Package Insert of DRSP-EE, additional contraindications related to the antimineralocorticoid activity of drospirenone (conditions that predispose to hyperkalemia):
* Renal insufficiency;
* Hepatic dysfunction;
* Adrenal insufficiency.
* 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;
* Before spontaneous menstruation has occurred following a delivery or abortion;
* Breastfeeding or within 2 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 posttreatment 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.
* Subjects with a diagnosis of the endometrial biopsy such as hyperplasia, atypical hyperplasia, carcinoma or any other abnormality judged clinically relevant by the investigator (This is applicable only for the subjects participating in the endometrial biopsy substudy).

Primary outcomes:
measure: Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)
timeFrame: 1 year (13 cycles)
measure: Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index)
timeFrame: 1 year (13 cycles)
Secondary outcomes:
measure: Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting
timeFrame: Every 28-day cycle for 13 cycles (one year total)
measure: Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
timeFrame: Every 28-day cycle for 13 cycles (one year total)
measure: Number of Participants With an Occurrence of Breakthrough Bleeding
timeFrame: Every 28-day cycle for 13 cycles (one year total)
measure: Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
timeFrame: Every 28-day cycle for 13 cycles (one year total)
measure: Number of Participants With an Occurrence of Early Withdrawal Bleeding
timeFrame: Every 28-day cycle for 13 cycles (one year total)
measure: Number of Participants With an Occurrence of Continued Withdrawal Bleeding
timeFrame: Every 28-day cycle for 12 cycles
measure: Average Number of Breakthrough Bleeding/Spotting Days
timeFrame: Every 28-day cycle for 13 cycles (one year total)
measure: Average Number of Withdrawal Bleeding/Spotting Days
timeFrame: Every 28-day cycle for 13 cycles (one year total)
Other outcomes:
Locations:
Study officials:
References:
citation: Witjes H, Creinin MD, Sundstrom-Poromaa I, Martin Nguyen A, Korver T. Comparative analysis of the effects of nomegestrol acetate/17 beta-estradiol and drospirenone/ethinylestradiol on premenstrual and menstrual symptoms and dysmenorrhea. Eur J Contracept Reprod Health Care. 2015;20(4):296-307. doi: 10.3109/13625187.2015.1016154. Epub 2015 Feb 25.
citation: Westhoff C, Kaunitz AM, Korver T, Sommer W, Bahamondes L, Darney P, Verhoeven C. Efficacy, safety, and tolerability of a monophasic oral contraceptive containing nomegestrol acetate and 17beta-estradiol: a randomized controlled trial. Obstet Gynecol. 2012 May;119(5):989-99. doi: 10.1097/AOG.0b013e318250c3a0.