Effects of concomitant treatment with an androgen on androgen metabolism, biochemical parameters, mood, fat, muscle and bone in women using an oral contraceptio

Phase 2

Completed

• Conditions: Hormonal anticonception; Pregnancy and Childbirth

• Registration Number: ISRCTN06414473
• Lead Sponsor: Pantarhei Bioscience BV (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-21
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. Healthy females between 18 and 35 years of age who are in need for OC
2. No use of hormonal contraceptive treatment for at least 3 months prior to randomisation
3. Willing to use an OC for 9 subsequent cycles
4. Willing to have a documented spontaneous cycle for baseline observation without the use of any hormonal contraceptive treatment
5. Sexually active women
6. Regular menstrual cycle (24 - 35 days) prior to screening
7. Body mass index (BMI) between (greater than or equal to) 18 and (less than or equal to) 35 kg/m^2
8. Good physical and mental health
9. Sign a written informed consent agreement

Exclusion Criteria

1. Contraindications for OC
2. Failure to ovulate during the documented spontaneous cycle for baseline observation
3. Use of hormonal contraceptive method during documented spontaneous cycle
4. Previous use of any hormonal contraceptive method during the last 3 months prior to randomisation
5. Use of any long term hormonal contraceptive method within 3 months after the limit of efficacy prior to screening
6. Androgen therapy during the 6 months prior to screening
7. Polycystic ovarian syndrome
8. Hyperandrogenism documented by free serum T value (greater than or equal to 9 pg/mL), severe acne and/or hirsutism at screening
9. No spontaneous menstruation has occurred following a delivery or abortion
10. Breastfeeding or within 2 months after stopping breastfeeding prior to the start of study medication and no spontaneous return of menstruation
11. Intention to become pregnant during the study
12. An abnormal cervical smear at screening
13. Any clinically significant abnormality following review of medical history, laboratory results and physical/gynaecological examination at screening
14. Treatment for any major psychiatric disorder in the previous 12 months or use of antidepressant medication prior to screening
15. History of/or current (treated) skin disorder (e.g. acne) which might be influenced by the study treatment
16. Use of any relevant treatment for a skin disorder at the time of screening
17. Use of one or more of the following medications: psychoactive drugs, anti-hypertensive drugs
18. Present use or use within 30 days prior to the start of the study medication of the following drugs: phenytoin, barbiturates, primidone, carbamazapine, 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)
19. Administration of any other investigational drug within 3 months prior to screening

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Androgen metabolism: albumin, Tot T, sex hormone binding globulin (SHBG), dehydroepiandrosterone sulfate (DHEA-S), 4-androstenedione and 3 alpha androstanediol; calculated free thyroxine intake (FTI) and Free T<br>2. Oestradiol (E2)<br>3. Lipid metabolism: total cholesterol, high density liprprotein (HDL), low density lipoprotein (LDL) and triglycerides<br>4. Bone turn-over: serum osteocalcin and serum bone specific alkaline phosphatase (bone formation), serum CTX-I (bone resorption) and urine CTX-II (cartilage turnover)<br><br>All parameters measured at screening/baseline and at the end of cycle 3, 6, 9, 12 and 16.

Secondary Outcome Measures

Name	Time	Method
1. General effect, satisfaction, health related quality of life, sexual functioning, menstrual symptoms and mood will be assessed by PRO instruments; measured at baseline and at the end of cycle 3, 6, 9 and 16<br>2. Body weight (weekly measurement) <br>3. Muscle, fat and bone: fat distribution (waist to hip ratio), percentage of fat mass, lean mass and bone mass, muscle strength (six muscles); measured at baseline and at the end of cycle 3, 9 and 16<br>4. Other endocrine parameters: fasting glucose, insulin, HbA1c, thyroid stimulating hormome (TSH), triiodothyronine (T3), cortisol, adrenocorticotropic hormone (ACTH); measured at screening/baseline and at the end of cycle 3, 9 and 16<br>5. Acceptability: discontinuation rates and reasons for discontinuations<br>6. Safety (vital signs, physical, gynaecological and breast examinations, safety lab, skin characteristics, bleeding data, [serious] adverse events, pregnancy), measured throughout the study