Pilot Study of Femring Estrogen Supplementation During Depo-Provera Initiation

This study has been completed.

Study NCT00563576 Information provided by Columbia University

First Received on November 21, 2007. Last Updated on September 14, 2011 History of Changes

Results First Received: October 11, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Metrorrhagia
Interventions:	Drug: Femring® Drug: DepoProvera ®

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from a Title X Family Planning Clinic in New York City.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Women seeking DMPA eligible to participate it 18 years old, English or Spanish speaking, had not used DMPA or Levonorgestrel intrauterine system in the preceeding 120 days. Women reporting oligomenorrheas (defined as fewer that 4 periods in the last 6 months), amenorrhea, or contraindications to either DMPA or estrogen were excluded.

Reporting Groups

	Description
Femring	Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
Depot Medroxyprogesterone Acetate (DMPA) Alone	Subjects will receive Depo-Provera intramuscular injection.

Participant Flow: Overall Study

	Femring	Depot Medroxyprogesterone Acetate (DMPA) Alone
STARTED	35	36
COMPLETED	21	22
NOT COMPLETED	14	14

Baseline Characteristics

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Reporting Groups

	Description
Femring	Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
Depot Medroxyprogesterone Acetate (DMPA) Alone	Subjects will receive Depo-Provera intramuscular injection.

Baseline Measures

	Femring	Depot Medroxyprogesterone Acetate (DMPA) Alone	Total
Number of Participants [units: participants]	35	36	71
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	35	36	71
>=65 years	0	0	0
Gender [units: participants]
Female	35	36	71
Male	0	0	0
Region of Enrollment [units: participants]
United States	35	36	71

Outcome Measures

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1. Primary:

Mean Number of Bleeding or Spotting Days [ Time Frame: 3 months ]

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2. Secondary:

Percentage of Users Who Were Satisfied With Femring [ Time Frame: 3 months ]

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3. Secondary:

Number of Subjects Who Receive a 2nd Injection of Depo-Provera [ Time Frame: 3 months ]

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4. Secondary:

Percentage of Subjects Who Receive a 3rd Injection [ Time Frame: 6 months ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Carolyn Westhoff
Organization: Columiba University
phone: 212-305-4805
e-mail: clw3@columbia.edu

Publications:

Alvarez-Sanchez F, Brache V, Thevenin F, Cochon L, Faundes A. Hormonal treatment for bleeding irregularities in Norplant implant users. Am J Obstet Gynecol. 1996 Mar;174(3):919-22.

Belsey EM, Machin D, d'Arcangues C. The analysis of vaginal bleeding patterns induced by fertility regulating methods. World Health Organization Special Programme of Research, Development and Research Training in Human Reproduction. Contraception. 1986 Sep;34(3):253-60.

Dieben TO, Roumen FJ, Apter D. Efficacy, cycle control, and user acceptability of a novel combined contraceptive vaginal ring. Obstet Gynecol. 2002 Sep;100(3):585-93.

Goldberg AB, Cardenas LH, Hubbard AE, Darney PD. Post-abortion depot medroxyprogesterone acetate continuation rates: a randomized trial of cyclic estradiol. Contraception. 2002 Oct;66(4):215-20.

Harel Z, Biro FM, Kollar LM, Rauh JL. Adolescents' reasons for and experience after discontinuation of the long-acting contraceptives Depo-Provera and Norplant. J Adolesc Health. 1996 Aug;19(2):118-23.

Hubacher D, Goco N, Gonzalez B, Taylor D. Factors affecting continuation rates of DMPA. Contraception. 1999 Dec;60(6):345-51.

Lim SW, Rieder J, Coupey SM, Bijur PE. Depot medroxyprogesterone acetate use in inner-city, minority adolescents: continuation rates and characteristics of long-term users. Arch Pediatr Adolesc Med. 1999 Oct;153(10):1068-72.

Novak A, de la Loge C, Abetz L, van der Meulen EA. The combined contraceptive vaginal ring, NuvaRing: an international study of user acceptability. Contraception. 2003 Mar;67(3):187-94.

Paul C, Skegg DC, Williams S. Depot medroxyprogesterone acetate. Patterns of use and reasons for discontinuation. Contraception. 1997 Oct;56(4):209-14.

Polaneczky M, Liblanc M. Long-term depot medroxyprogesterone acetate (Depo-Provera) use in inner-city adolescents. J Adolesc Health. 1998 Aug;23(2):81-8.

Rager KM, Fpwler A, Omar HA. Successful treatment of depot medroxyprogesterone acetate-related vaginal bleeding improves continuation rates in adolescents. ScientificWorldJournal. 2006 Mar 19;6:353-5.

Rickert VI, Tiezzi L, Lipshutz J, León J, Vaughan RD, Westhoff C. Depo Now: preventing unintended pregnancies among adolescents and young adults. J Adolesc Health. 2007 Jan;40(1):22-8.

Said S, Omar K, Koetsawang S, Kiriwat O, Srisatayapan Y, Kazi A, Ajmal F, Wynter HH, Pretnar-Darovec A, Benitez IB. A multicentered phase III comparative clinical trial of depot-medroxyprogesterone acetate given three-monthly at doses of 100 mg or 150 mg: II. The comparison of bleeding patterns. World Health Organization. Task Force on Long-Acting Systemic Agents for Fertility Regulation Special Programme of Research, Development and Research Training in Human Reproduction. Contraception. 1987 Jun;35(6):591-610.

Said S, Sadek W, Rocca M, Koetsawang S, Kirwat O, Piya-Anant M, Dusitsin N, Sethavanich S, Affandi B, Hadisaputra W, Kazi A, Ramos RM, d'Arcangues C, Belsey EM, Noonan E, Olayinka I, Pinol A. Clinical evaluation of the therapeutic effectiveness of ethinyl oestradiol and oestrone sulphate on prolonged bleeding in women using depot medroxyprogesterone acetate for contraception. World Health Organization, Special Programme of Research, Development and Research Training in Human Reproduction, Task Force on Long-acting Systemic Agents for Fertility Regulation. Hum Reprod. 1996 Oct;11 Suppl 2:1-13.

Sangi-Haghpeykar H, Poindexter AN 3rd, Bateman L, Ditmore JR. Experiences of injectable contraceptive users in an urban setting. Obstet Gynecol. 1996 Aug;88(2):227-33.

Speroff L. Efficacy and tolerability of a novel estradiol vaginal ring for relief of menopausal symptoms. Obstet Gynecol. 2003 Oct;102(4):823-34.

[No authors listed] Multinational comparative clinical evaluation of two long-acting injectable contraceptive steroids: noresthisterone oenanthate and medroxyprogesterone acetate. 2. Bleeding patterns and side effects. Contraception. 1978 May;17(5):395-406.

Responsible Party:	Angela Dempsey-Fanning, MD, MPH, Columbia University
ClinicalTrials.gov Identifier:	NCT00563576 History of Changes
Other Study ID Numbers:	AAAC6363, Depo with Femring
Study First Received:	November 21, 2007
Results First Received:	October 11, 2010
Last Updated:	September 14, 2011
Health Authority:	United States: Institutional Review Board