Contraceptive Pill and Hormonal Vaginal Ring in Women With Polycystic Ovary Syndrome

This study is currently recruiting participants.
Verified May 2012 by University of Oulu
Sponsor:
Information provided by (Responsible Party):
University of Oulu
ClinicalTrials.gov Identifier:
NCT01588873
First received: March 28, 2012
Last updated: May 3, 2012
Last verified: May 2012
  Purpose

The main aims of this study are:

  • to investigate and compare the effects of long lasting use (59 weeks) of vaginal and oral contraceptives on androgen secretion, insulin and glucose metabolism, lipid profile, and serum levels of SHBG and hs-CRP in women with PCOS.
  • to compare the metabolic effects of oral and vaginal combined contraceptives and to find out whether oral or transvaginal contraceptive can be recommended to a particular group of women, for example in women with increased metabolic risks.
  • to clarify whether the unfavourable effects of combined contraceptives diminish with time (after use of one year).

Condition Intervention Phase
Adverse Effect of Oral Contraceptives, Sequela
Drug: oc:E-E-desogestrel/vaginal ring:E-E -ethonogestrel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Contraceptive Pill and Hormonal Vaginal Ring on Hormonal, Inflammatory and Metabolic Parameters in Women of Reproductive Age With Polycystic Ovary Syndrome (PCOS).

Resource links provided by NLM:


Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • Change in Matsuda index during the oral contraceptive pill (E-E-desogestrel)/vaginal ring (E-E -ethonogestrel) [ Time Frame: Change from baseline in Matsuda index at 59 weeks of treament ] [ Designated as safety issue: No ]
    Calculation of the Matsuda index according to the following equation: [10000 / √((fasting glucose x fasting insulin)x (Gmeanogtt x Imeanogtt))]


Secondary Outcome Measures:
  • Change in high sensitive C-reactive protein (mg/l) during the oral contraceptive pill (E-E-desogestrel)/vaginal ring (E-E -ethonogestrel) [ Time Frame: Change from baseline in serum CRP concentrations at 59 weeks of treament ] [ Designated as safety issue: No ]
  • Change in Free Androgen Index during the oral contraceptive pill (E-E-desogestrel)/vaginal ring (E-E -ethonogestrel) [ Time Frame: Change from baseline in Free Androgen Index at 59 weeks of treament ] [ Designated as safety issue: No ]
    Calculation by using the equation 100×T (nmol/l)/SHBG (nmol/l).


Estimated Enrollment: 42
Study Start Date: April 2012
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oral contraceptive pill Drug: oc:E-E-desogestrel/vaginal ring:E-E -ethonogestrel

The OC or vaginal ring will be used in 9 weeks periods followed by one week's break each.

After a wash-out period of at least 2 months of any previous hormonal contraceptives all examinations will be performed at the 1st to 5th day of the menstruation cycle at baseline and then at the 9th, 29th and 59th week and the last 1 month after stopping contraception.

Blood samples will be collected between 07 and 10 AM after an overnight fast and during the follicular phase or at any time in cases of amenorrhea. After centrifugation serum is filled in eight tubes with at least 2 ml of serum in each, and immediately frozen at -70ºC as well as one tube of plasma. Every tube will be marked appropriately. Fasting plasma glucose and HbA1c will be analysed at once at every appointment.

Other Name: Mercilon, Nuva-Ring
Active Comparator: Contraceptive ring Drug: oc:E-E-desogestrel/vaginal ring:E-E -ethonogestrel

The OC or vaginal ring will be used in 9 weeks periods followed by one week's break each.

After a wash-out period of at least 2 months of any previous hormonal contraceptives all examinations will be performed at the 1st to 5th day of the menstruation cycle at baseline and then at the 9th, 29th and 59th week and the last 1 month after stopping contraception.

Blood samples will be collected between 07 and 10 AM after an overnight fast and during the follicular phase or at any time in cases of amenorrhea. After centrifugation serum is filled in eight tubes with at least 2 ml of serum in each, and immediately frozen at -70ºC as well as one tube of plasma. Every tube will be marked appropriately. Fasting plasma glucose and HbA1c will be analysed at once at every appointment.

Other Name: Mercilon, Nuva-Ring

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • women aged between 18 to 40 years
  • diagnosed PCOS (Rotterdam criteria)
  • healthy, no medications
  • no use of hormonal contraceptives or wash-out period of at least two months
  • no contraindications to hormonal contraception

Exclusion Criteria:

  • regular smoking
  • excessive alcohol use
  • pregnancy or breastfeeding
  • oversensitivity to active ingredients
  • migraine with focal aura
  • severe or multiple risk factors to thrombosis
  • diagnosed or suspected cancer
  • diagnosed or suspected estrogen-dependent tumor
  • acute or chronic hepatocellular disease -related abnormal liver function
  • hepatic adenomas or carcinomas
  • undiagnosed abnormal vaginal bleeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588873

Contacts
Contact: Laure C Morin-Papunen, PhD +358 8 3154109 lmp@cc.oulu.fi

Locations
Finland
Department of Obstetrics and Gynaecology, University Hospital of Oulu Recruiting
Oulu, Finland, 90029
Contact: Laure C Morin-Papunen, PhD    +358 8 3154109    lmp@cc.oulu.fi   
Contact: Juha S Tapanainen, PhD    +358 8 3153172    juha.tapanainen@oulu.fi   
Principal Investigator: Anni S Rantala, med student         
Sub-Investigator: Johanna Puurunen, MD         
Sponsors and Collaborators
University of Oulu
Investigators
Principal Investigator: Laure C Morin-Papunen University of Oulu
  More Information

Publications:

Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT01588873     History of Changes
Other Study ID Numbers: 106/2011
Study First Received: March 28, 2012
Last Updated: May 3, 2012
Health Authority: Finland: Ethics Committee

Keywords provided by University of Oulu:
Oral contraceptive pill
Hormonal contraceptive ring
Polycystic ovary syndrome

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Contraceptive Agents
Desogestrel
Contraceptives, Oral
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on April 17, 2014